SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma
Phase 2
Recruiting
- Conditions
- Interventions
- Registration Number
- NCT06323239
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 148
Inclusion Criteria
- Diagnosed as recurrence/metastatic NPC
- Histopathological diagnosis of NPC(WHO II/III)
- ECOG 0-1 point
- No treatment to r/mNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
- No contraindications to immunotherapy and chemoradiotherapy;
- At least one lesion could receive SBRT safely;
- Subject must have a measurable target lesion based on RECIST v1.1;
- Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/ L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
- Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
- Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
- Take effective contraceptions during and three months after treatment;
- Patients must be informed of the investigational nature of this study and give written informed consent.
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Exclusion Criteria
- Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and cisplatin;
- Unexplained fever > 38.5 #, except for tumor fever;
- Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);
- Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;
- Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment; Have known allergy to large molecule protein products or any compound of study therapy;
- Pregnant or breastfeeding;
- Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
- Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
- Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SBRT+LDRT+PD-1+Chemotherapy SBRT Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment. SBRT+LDRT+PD-1+Chemotherapy Low-dose Radiotherapy (LDRT) Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment. SBRT+LDRT+PD-1+Chemotherapy Toripalimab Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment. SBRT+LDRT+PD-1+Chemotherapy IMRT Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment. SBRT+LDRT+PD-1+Chemotherapy Gemcitabine Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment. SBRT+LDRT+PD-1+Chemotherapy Cisplatin Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment.
- Primary Outcome Measures
Name Time Method Progression-free survival up to 12 months Defined as the time from randomization to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Objective Response Rate up to 12 months The percentage of patients with CR and PR assessed according to RECIST v1.1.
Overall Survival up to 12 months Defined as the time from randomization to death from any cause.
Disease Control Rate up to 12 months The proportion of patients who have achieved complete response, partial response and stable disease according to RECIST v1.1.
Adverse Events up to 12 months All adverse event or serious adverse event that occurred during the study period according to CTCAE v 4.03
QoL up to 12 months Assessed by EQ-5D-5L questionnaire
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China